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Completed

NCT Number: NCT00475514

A Controlled Trial to Investigate the Efficacy and Safety of Frovatriptan to Prevent Menstrual Migraine

Although the predictability of an MRM headache attack lends itself to preventative treatment, there are currently no drugs specifically indicated for the prevention of MM. Such preventative therapies might be administered either short term (during the time around the period otherwise known as the peri-menstrual period or PMP) or continuously throughout the menstrual cycle.

Frovatriptan has been developed for the management of migraine and is already licensed for use as an acute treatment for this condition. Previous well controlled clinical trials have highlighted the potential of frovatriptan as a short-term preventative medication for MM. This clinical trial was meant to further explore this indication for frovatriptan in an expanded population.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

See above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pre-menopausal females diagnosed as suffering from MRM aged 15 years and over, that fit the criteria for 'difficult to treat'

Treatment and study plan

Frovatriptan 2.5mg QD

Drug

Frovatriptan 2.5 mg BID

Drug

Placebo

Drug

Primary outcomes

  1. Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs

Secondary outcomes

  1. Incidence of MRM headache

  2. Maximum headache intensity

  3. Incidence of moderate or severe MRM headaches

  4. Number of MRM headache free days during treated PMPs

  5. Incidence of MRM headache associated symptoms (e.g. photophobia, phonophobia, nausea and vomiting)

  6. Functional impairment during treatment phase

  7. Time to onset (days) of MRM headache (during the treated PMP and until five days post treatment)

  8. Time to onset of first post-treatment migraine Incidence of intercurrent migraine outside of the peri-menstrual period Use of rescue medication

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study title

A Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, and Safety of Oral Frovatriptan in the Prevention on Menstrually-related Migraine (MRM) Headaches in a 'Difficult to Treat' Population

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
May 21, 2007
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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